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VOLUME
02:
ISSUE 13
This
investing strategy is one that investors are familiar with especially during
the previous stock market boom when tech reigned supreme. Buy the
"picks
and shovels" company! This term is attributed to the Gold Rush
of the 1840's-1850's when people were storming San Francisco looking for
their share of riches. As we all know very few actually struck gold
whole the majority ended up worst than before they. However, there
were beneficiaries of the Gold Rush that amassed great wealth through supplying
these gold seekers with the "picks and shovels".
The tremendous growth in the technology
sector this last decade created many of today's household names. Personal
computers became an amenity to every home and the internet became instilled
into our everyday lives. Unfortunately, investing in the internet
proved to be disastrous as dotcom after dotcom seemingly dissipated as
quickly as their astronomic rise. Perhaps you were one of the millions
of investors that got caught in the frenzy. Don't blame yourself
because we were all blinded.
Despite the carnage, a new industry
was born and with that came the creation of the new industrial leaders.
Investors that purchased the "picks and shovels" of the tech sector
amassed great fortunes even with the recent declines we have experienced
the last three years. There are many winners but one company distinguishes
itself above the rest.
Cisco Systems (CSCO)
benefited
from the increase in net usage regardless of what destinations or applications
were utilized. Increase in usage meant incremental revenue and profits
for the router company. It didn't matter what websites people were
going to or who provided hosting services to these websites as long as
people were utilizing these services.
However, not everyone saw Cisco for
its potential. If you invested $2400 on March 26, 1990 Cisco's first
day of trading, you would've owned 100 shares. That doesn't seem
like a very large investment but today those same 100 shares would have
grown to 28,800 shares or approximately $518,000. 2300%
return is the kind of stuff every investor dreams of. The chart above
illustrates Cisco's metamorphosis from no name company to a pillar of corporate
America. On the first day of trading the company's shares were worth a
split adjusted price of $0.08 per share.
Today's long anticipated profile
features a company that is also in the "picks and shovels" business except
this time the industry is biotechnology. Their unique business model
allows them to sit back and wait for the Photodynamic Therapy (PDT)
industry
to gain additional FDA approvals. Each FDA approval means additional
revenue and profits for the company.
There is an added bonus because this
company recently became the first company to receive
FDA approval for EVLT, a new micro-invasive technique is available
which has been developed for the treatment of varicose veins.
This means that unlike most biotechs, the company has real revenues and
is expected to be cash flow positive in 2002.
The company has the luxury of spending
almost no money in the FDA approval process because of the company's partnerships
with the four major PDT drug makers. These drug makers are in turn spending
millions of dollars to get their drugs approved. For a company in
its initial phase of growth their sales in 2001 were impressive and in
2002 cash flow positive should be easily obtainable.
There are some marquee names that
are considered to be "smart money" who are associated with this company.
The stock has begun trading today
for the first time through the RTO process described in our January
16th edition. The company completed a reverse merger into a fully reporting
"Shell" company, and opened for trading on the American Stock Exchange.
Companies reverse merging into shells with preexisting listings is no rarity,
but completing a merger into an unlisted shell, and then opening for trading
on the American Stock Exchange is unheard of.
Without further delay we present
our February profile:
February Profile: Diomed Corporation
(AMEX: DIO)
Stock Listing: AMEX: DIO
Estimated Shares Issued and Outstanding:
31.3
million
Estimated Public Float: 9.2 Million
Opening Price: $6.95
Market Capitalization: $218 Million
52 High and Low Since Merger: $9-$5.45
Corporate Web Site: http://www.diomedinc.com/
Diomed Corp, based out
of Massachusetts, opened for trading today on the American Stock Exchange
at $6.95 per share, and we believe the stock should be accumulated up to
$8.00
in the short term. Long term investors could enjoy upside
potential considerably higher based on the growth of the PDT and EVLT industries.
The company manufactures and markets
lasers and fiber optics which are used in unique treatment protocols for
many types of cancer. In addition, Diomed is the first
company in approved by the FDA for the treatment of EVLT which known as
varicose
vein removal.
The following is a review of Diomed's
products and how they work:
Photo Dynamic Therapy (PDT)
Diomed manufacturers and markets
the lasers used in a revolutionary treatment known as Photo Dynamic
Therapy, or PDT for short. The FDA has approved the use of Diomed's
lasers and fiber in a "Modality", or three step treatment with Axcan
Pharmaceutical's (AXCA)
Photofrin. Photofrin is used for certain treatments associated
with throat and lung cancer but has the potential to be administered for
other treatments as well.
Photodynamic therapy, or PDT, uses
a light sensitive drug, such as Photofrin, and laser light to kill cancer
cells. The drug is injected into the patient and concentrates in tumors.
Photofrin remains inactive until it is combined with a special laser light.
The light activates the drug which produces a toxic form of oxygen that
destroys tumor tissue.
For endobronchial lung tumors, the
patient is injected with Photofrin. Two days later, laser light is delivered
through a small optical fiber inserted through a bronchoscope, an instrument
used for examination of the bronchial tubes. One to two days after the
laser treatment, destroyed tumor tissue is removed during a second bronchoscopy
procedure. The procedure is typically performed on an outpatient basis;
however, an overnight hospital stay may be recommended for some patients.
After treatment the patient must
stay out of the sun for a few days waiting for the remainder of the drug
to be absorbed into the tissues. PDT offers several advantages over standard
treatment. The primary benefits of lung PDT are the limited side effects,
preservation of the lung, and the fact that PDT can be repeated if necessary.
The laser costs upwards of $50,000
not including a $9,000 installation fee. Diomed has about a 50% gross profit
on devices. In the area of disposables the company's stated goal
is a 65% margin on the one-time fiber used in each procedure. However,
the company receives $500 to $550 for the fiber used in each procedure,
and their cost is approximately $150.
For competitors, the barriers to
entry are very high as the FDA Approval for this "Modality" requires Diomed's
laser and fiber to be used in every procedure. Diomed has
partnerships with the four major PDT companies, all of whom have new drugs
in the FDA Pipeline which could use Diomed's lasers and fiber in
the treatments modalities.
It is estimated the cost of completing
the FDA Approval process for a new drug is approximately $150 million.
Less than 40% of new drugs which begin the approval process ever receive
final FDA Approval. Diomed is in the enviable position of profiting
from the investments made by their four drug company partners because the
company doesn't finance the costs associated with the approval process.
This minimizes the downside risk and maximizes the upside potential for
investors because there is no fear of the company running out of capital.
This is unlike most biotech companies that find themselves in a precarious
financial state due to the millions of dollars poured into the FDA approval
process.
PDT- The "Off Branding Market"
Although the FDA has approved the
three part "Modality" for treatment of specific types of throat and lung
cancer. This modality is proven to be effective in treating other types
of cancer as well. Doctors are using the modality in a practice known as
"Off
Branding".
FDA regulations prohibit Diomed and
Axcan
Pharmaceutical (manufacturer of Photofrin) from marketing the modality
for treatment of any types of cancer which has not been approved by the
FDA.
However, doctors are not restricted
in the same manner and are now routinely prescribing the use of this modality
for many types of cancer. In fact, Diomed estimates that as much
as 50% of its current revenues could be generated in "Off Branding" procedures.
Insurance companies and Medicare
are providing full coverage benefits for all treatments. Doctors, Hospitals,
and Insurance Companies are embracing this relatively new therapy as it
has proven to be a very effective treatment for cancer, but is far less
costly, has very few side effects, and requires far less follow-up treatment
than its counterparts, chemotherapy and radiation.
Future Of Photodynamic Therapy (PDT)
The table above illustrates the additional
treatments PDT drug makers are aiming to gain FDA approval for. This will
potentially impact Diomed's sales in the future as each additional
FDA approval could mean additional revenues and profits for Diomed. Approximately
40% of these new drugs will eventually find their way to market. The table
represents hundreds of millions in potential revenue for Diomed,
with no associated up front costs.
The company has sold about 100 laser
systems to its four drug company partners, and the Diomed laser
and fiber is being used in clinical trials by these companies.
FDA approvals are granted for the
three stage treatment or "Modality"- which is the combination of the drug,
specific laser, and fiber. FDA regulations prohibit the use of any substitute
lasers or fibers in the treatment, which creates a very formidable barrier
to entry for other laser and fiber manufacturers. Once approval is granted,
a competing company would have to replicate the clinical trials with their
own equipment to achieve an FDA approval, absorbing the cost out of their
own pocket. The drug manufacturers have no incentive to seek alternative
suppliers of lasers and fiber as their profits come from the sale of the
drug. As long as Diomed is a reliable supplier of equipment, their
drug company partners will be content with their profits.
The next anticipated pending FDA
Approval which represents a major commercial opportunity for the company
is expected to be granted in the fall of this year. Axcan is in clinical
trials for a modality to treat "Barrett's Esophagus", more commonly
known as Acid Reflex Syndrome. The market is estimated to be 10
times that of Photofrin, so Diomed's growth could be explosive after
this approval is granted.
EndoVenous Laser Treatment (EVLT?)
On January 22, 2002, Diomed
announced it had been granted the long awaited FDA Approval for EVLT?,
a new and revolutionary treatment for varicose veins. The company's
breakthrough procedure has been in use outside of the United States but
the recent FDA approval means the treatment will be available domestically.
Diomed's EVLT treatment has even been the subject of a feature on Good
Morning America and New
York Times.
Diomed believes demand will
immediately surface for this newly approved procedure, and as much as 68%
of its 2002 revenues could be derived from EVLT?.
EndoVenous Laser Treatment
is the most painless and effective way to remove varicose veins which affects
one of every two people 50 or older, and about 15 percent of men and 25
percent of women overall according to the Society of Cardiovascular and
Interventional Radiology. For some varicose veins is simply a cosmetic
issue but they can also cause aches and pains, cramp and leg swelling.
A medical study conducted 15 years ago in Switzerland showed that those
with varicose veins also stand a 50 percent higher risk of developing blood
clots or leg ulcers.
EVLT? is a quick, minimally
invasive laser procedure that leaves no scar, has a short and relatively
pain free post-operative recovery period and is performed under local anesthesia
in the doctor's treatment room. A patient comes in lies on an examining
table and has an IV placed in their saphenous vein at knee level. The skin
is just nicked when a laser fiber is inserted into the vein, and it goes
up to the groin area. The doctor then numbs the vein, and turns on the
laser. It's highly targeted energy heats and seals the vein shut.
The market for EVLT is enormous
as hundreds of thousands of operations are done for varicose veins a year
in the United States. Varicose vein sufferers currently have two options,
either get surgery to remove the vein or injection therapy to close it
up. Surgical ligation, or removal of the saphenous vein in the leg,
fails about 10 percent of the time. Patients are required to be placed
under anesthesia, there is a two-week recovery period, and it often takes
a second procedure to really see results. Side affects of the surgery include
pain, bruising and scarring. Another technique used to battle varicose
veins is ultrasound-guided sclerotherapy, which involves injecting an irritant
into the saphenous vein to close it up. It only works permanently about
50 percent of the time.
There is so much interest and demand
for this new treatment, Diomed has set up a web site which explains
the entire treatment process. You can even locate a treatment facility
through this site. Check out http://www.summerlegs.com/
for complete information.
Diomed's EVLT? is a simple
and relatively painless solution with 98% success rate. It requires
approximately 45 minutes to complete the treatment. Women and men worldwide
who have been plagued by unsightly varicose veins now have a reasonable
solution to their problem.
Financial Outlook
Audited 2001 financials for Diomed
will be out very shortly. However, based on revenues through the end of
September, the company will achieve approximately $8 to $8.5 million in
sales in 2001.
Discussions with management lead
us to estimate revenues in 2002 to be around $18 million. That would
be an increase of over 113% from 2001 estimates. Revenues
from the newly FDA Approved EVLT? procedure are expected to represent
68% of sales in 2002 but keep in mind these estimates do not include additional
FDA approval in the PDT sector. Diomed expects to turn profitable this
year.
As more clinics purchase lasers from
Diomed
in
order to offer these procedures to patients, the demand for the disposables
should increase dramatically, and margins will improve.
For 2001 losses are anticipated for
the year due to the high cost of R & D but the company expects to turn
cash flow positive in 2002 and could make as much as $6-$7 million in 2003
off current FDA approved products. These figures do not factor in
additional FDA approvals for PDT treatments.
The company manufactures its own
lasers, but the fiber component is manufactured by a third party. Just
prior to going public, Diomed completed a $10 million private placement
which will partially be used to purchase the fiber manufacturer, thereby
increasing its profit margins on the disposable side of its business.
Sales should more than double this
year, and increase nearly 60% the following. That equates to a 275% percent
growth rate over the next two years with no additional FDA Approvals. This
type of revenue growth is very rare for companies that are in an industry
that is just beginning to blossom.
This Fall should bring another FDA
Approval from Axcan Pharmaceuticals for the PDT treatment of "Barrett's
Esophagus". The market for this product is estimated to be 10 times
the market for current PDT applications. This provides shareholders with
a potential windfall event for the stock price.
Smart Money
Below you will find the names of
several high profile early stage investors in Diomed who helped
finance the company's growth as a private company. Here are four key individual
names who have invested personally through funds they control:
Sir Richard Branson- High Profile
Founder of Virgin International (Virgin Airlines and Records)
Jack Rivkin- Executive Vice President
at Citigroup Investments and former head of research at Smith Barney
Jonathan Cohen- JHC Capital Management
- Formerly at Merrill Lynch and Smith Barney
Robert Lessin- Chairman of Wit
SoundView Group
Keep in mind that although these are
some of the biggest names on Wall Street, their involvement does not guarantee
that Diomed will perform better than other companies we have covered.
Investors should not view their investment as an endorsement. These investors
probably diversify their holdings by investing in many development stage
companies.
With that being said, the fact they
are involved in Diomed clearly shows that the company has enough potential
to attract big time names.
Conclusion
The SmallCap Digest
has scoured
thousands of companies to find you the hidden gems. The information
we have provided you on Diomed is coming to you before the rest of the
financial community knows much about this company. As with any investment
there is risk, but like the early investors Cisco, the courage to act in
the early stages may lead to significant rewards.
Today is the first day of trading
for Diomed, and because they went public through an RTO you are
on a level playing field with other open market investors.
We believe Diomed should be
accumulated up to $8.00 for a move to above $11
during 2002. Going forward, the further development and FDA approvals in
the PDT industry coupled with Diomed's EVLT treatments could mean significant
upside to the company's performance.
Investing in "Picks and shovels"
companies have paid off handsomely for investors in the past. Diomed is
one of the few biotechs that are positioned to profits from FDA approvals
without spending its own money. This coupled with the company's position
as the industry leader in EVLT presents a very compelling opportunity to
own a future superstar.
Investors with a tolerance for high
risk and high reward opportunities should consider Diomed (DIO) for
their portfolios.
For a due diligence package
on Diomed Inc., you can receive a free investor information kit by contacting
Jason Sundar toll free at 1-888-400-0643.
D I S C
L A I M E R :
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